Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx

双侧声带麻痹(BVFP)是一种严重且经常危及生命的疾病。大约7,000 在美国，每年都有患者遭受这种瘫痪的打击。更多的人容易患上 医学上不太发达的国家(例如印度和中国，&gt；80,000)。喉返神经携带 支配外展肌和内收肌的运动纤维 声带的声音。如果双侧神经受损，通常会发生再生，但神经再支配 吸气性和反射性声门闭合运动神经元在这些拮抗神经元之间部分交错分布 肌肉。鉴于神经再支配的合并性，喉部仍处于瘫痪或无功能状态。 声带部分激光切除(声带切断术)是BVFP改善通气性的标准护理。 然而，它只是轻微地增加了通过口腔的气流，损害了声音，并影响了吞咽。 通过渴望。一种更自然的方法是通过电刺激恢复声带开放 佩戴可植入喉部起搏器的PCA肌肉。此外，联动神经再支配的肌肉 对电刺激特别敏感。单侧喉部起搏的临床试验 私家侦探在1996年。在这项研究中，发现起搏时的通气量略高于起搏时的通气量。 声带切断术，未发现发音质量下降或吞咽功能下降。最近，一种更高级的 植入式脉冲发生器(EonCTM)已经商业化。它有一个多路可编程 允许独立刺激两侧PCA肌肉的功能。在《纽约时报》的一项初步研究中 犬，通过一对埋置的刺激电极激活双侧PCA肌肉。 这些动物的呼吸和运动能力恢复到正常水平，没有任何吸入。在……里面 这项临床研究提案的主要目标将是比较双侧喉起搏与脊髓切开术和 注意通风和发声效果。在起搏患者中，我们还将比较双侧起搏的影响 而不是在这些结果指标上采取单边刺激。喉部功能电复苏术 刺激应为BVFP提供一种更好的治疗方法。

Bilateral vocal fold paralysis (BVFP) is a serious and often life-threatening condition. Approximately 7,000 patients are stricken by this paralysis each year in the United States. A much larger number are susceptible in less medically advanced countries (e.g. India and China, > 80,000). The recurrent laryngeal nerve carries motor fibers that innervate both the abductor (posterior cricoarytenoid, PCA) muscle and the adductor muscles of the vocal folds. If the nerves are injured on both sides, regeneration usually occurs but the reinnervation by inspiratory and reflex glottic closure motoneurons becomes partially crisscrossed between these antagonistic muscles. The larynx remains paralyzed or nonfunctional in view of the synkinetic nature of the reinnervation. Partial laser resection of the vocal fold (cordotomy) is the standard of care for BVFP to improve ventilation. However, it only mildly increases airflow through the mouth, damages the voice, and compromises swallowing through aspiration. A more natural approach is to restore vocal fold opening through electrical stimulation of the PCA muscle with an implantable laryngeal pacemaker. Further, synkinetically reinnervated muscles are particularly responsive to electrical stimulation. A clinical trial of unilateral laryngeal pacing was conducted by the PI in 1996. In this study, it was found that ventilation with pacing was marginally greater than with cordotomy, and there was no deterioration of voice quality or swallowing function. Recently, a more advanced implantable pulse generator (EonCTM) has become available commercially. It has a multi-programmable feature that allows independent stimulation of the PCA muscles on both sides. In a preliminary study in the canine, the PCA muscles were bilaterally activated through a pair of implanted stimulation electrodes. Ventilation and exercise performance was restored to a normal level without any aspiration in these animals. In this clinical research proposal, the primary goal will be to compare bilateral laryngeal pacing to cordotomy with respect to ventilation and voice outcomes. In the pacing patients, we will also compare the impact of bilateral versus unilateral stimulation on these outcome measures. Laryngeal reanimation with functional electrical stimulation should provide a superior treatment approach for BVFP.